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Published in: Clinical Drug Investigation 7/2013

01-07-2013 | Original Research Article

Twenty-Four-Hour Ambulatory Blood Pressure Reduction with a Perindopril/Amlodipine Fixed-Dose Combination

Author: Viktor L. Nagy

Published in: Clinical Drug Investigation | Issue 7/2013

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Abstract

Background

Most hypertensive patients need more than one agent to achieve blood pressure (BP) control. The fixed dose combinations can provide effective 24-h BP control, which is essential in hypertension management.

Aims

The primary objectives of the PErindopril/Amlodipine Reduction of blood pressure Level (PEARL) ABPM substudy were to assess the effect of a perindopril/amlodipine fixed-dose combination on mean 24-h BP, daytime BP, and nighttime BP in a subgroup of PEARL patients. Secondary objectives included assessment of office BP, metabolic parameters (blood glucose and lipids), heart rate, and safety and tolerability.

Methods

PEARL was a 3-month observational study with a perindopril/amlodipine fixed-dose combination for treatment of outpatients with essential hypertension uncontrolled by prior treatment (office BP ≥140/90 mmHg or ≥130/80 mmHg in those at high/very high cardiovascular risk). In this ABPM substudy of PEARL, treatment efficacy was assessed by 24-h ABPM. At inclusion, previous angiotensin-converting enzyme (ACE) inhibitors and/or calcium channel blockers (CCBs) were replaced by a perindopril/amlodipine fixed-dose combination at a dosage (5/5, 5/10, 10/5, or 10/10 mg) chosen by the physician and uptitrated at month 1, if required. ABPM and office BP measurements were assessed at inclusion, month 1, and month 3. Metabolic effects, heart rate, and adverse events were also monitored.

Results

Mean age of the 262 ABPM patients (144 males) was 60.4 ± 11.7 years, and mean baseline office brachial systolic BP/diastolic BP was 159.8 ± 16.0/94.3 ± 10.3 mmHg. After 3 months, the perindopril/amlodipine fixed-dose combination reduced mean 24-h ambulatory BP from 146.1/84.3 to 127.6/75.9 mmHg (p < 0.001). Mean office BP decreased to 131.1/80.0 mmHg (p < 0.001). Results were consistent in subgroups, defined by cardiovascular comorbidities or previous treatments. Favorable metabolic and heart rate effects were observed, and no serious adverse events were reported.

Conclusions

Further effective, safe, and sustained 24-h ambulatory BP and office BP reductions were obtained by switching from ACE inhibitors and/or CCBs to a perindopril/amlodipine fixed-dose combination in outpatients with uncontrolled essential hypertension in a practice setting. For this type of patient, the use of a perindopril/amlodipine fixed-dose combination can be considered an effective and safe option to normalize BP.
Literature
1.
go back to reference Krause T, Lovibond K, Caulfield M, et al. Management of hypertension: summary of NICE guidance. BMJ. 2011;343:474–8.CrossRef Krause T, Lovibond K, Caulfield M, et al. Management of hypertension: summary of NICE guidance. BMJ. 2011;343:474–8.CrossRef
2.
go back to reference Coats AJ, Radaelli A, Clark SJ, et al. The influence of ambulatory blood pressure monitoring on the design and interpretation of trials in hypertension. J Hypertens. 1992;10:385–91.PubMedCrossRef Coats AJ, Radaelli A, Clark SJ, et al. The influence of ambulatory blood pressure monitoring on the design and interpretation of trials in hypertension. J Hypertens. 1992;10:385–91.PubMedCrossRef
3.
go back to reference Centers for Disease Control and Prevention. Vital signs: prevalence, treatment, and control of hypertension–United States, 1999–2002 and 2005–2008. MMWR Morb Mortal Wkly Rep. 2011;60:103–8. Centers for Disease Control and Prevention. Vital signs: prevalence, treatment, and control of hypertension–United States, 1999–2002 and 2005–2008. MMWR Morb Mortal Wkly Rep. 2011;60:103–8.
4.
go back to reference Mancia G, De Backer G, Dominiczak A, et al. 2007 Guidelines for the management of arterial hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J. 2007;28:1462–536.PubMed Mancia G, De Backer G, Dominiczak A, et al. 2007 Guidelines for the management of arterial hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J. 2007;28:1462–536.PubMed
5.
go back to reference Mancia G, Laurent S, Agabiti-Rosei E, et al. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J Hypertens. 2009;27:2121–58.PubMedCrossRef Mancia G, Laurent S, Agabiti-Rosei E, et al. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J Hypertens. 2009;27:2121–58.PubMedCrossRef
6.
go back to reference Clement DL, De Buyzere ML, De Bacquer DA, et al. Prognostic value of ambulatory blood-pressure recordings in patients with treated hypertension. N Engl J Med. 2003;348:2407–15.PubMedCrossRef Clement DL, De Buyzere ML, De Bacquer DA, et al. Prognostic value of ambulatory blood-pressure recordings in patients with treated hypertension. N Engl J Med. 2003;348:2407–15.PubMedCrossRef
7.
go back to reference Dolan E, Stanton A, Thijs L, et al. Superiority of ambulatory over clinic blood pressure measurement in predicting mortality: the Dublin outcome study. Hypertension. 2005;46:156–61.PubMedCrossRef Dolan E, Stanton A, Thijs L, et al. Superiority of ambulatory over clinic blood pressure measurement in predicting mortality: the Dublin outcome study. Hypertension. 2005;46:156–61.PubMedCrossRef
8.
go back to reference Jamerson K, Weber MA, Bakris GL, et al. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008;359:2417–28.PubMedCrossRef Jamerson K, Weber MA, Bakris GL, et al. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008;359:2417–28.PubMedCrossRef
9.
go back to reference Dahlof B, Sever PS, Poulter NR, et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet. 2005;366:895–906.PubMedCrossRef Dahlof B, Sever PS, Poulter NR, et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet. 2005;366:895–906.PubMedCrossRef
10.
go back to reference Gradman AH, Basile JN, Carter BL, et al. Combination therapy in hypertension. J Clin Hypertens (Greenwich). 2011;13:146–54.CrossRef Gradman AH, Basile JN, Carter BL, et al. Combination therapy in hypertension. J Clin Hypertens (Greenwich). 2011;13:146–54.CrossRef
11.
go back to reference Dolan E, Stanton AV, Thom S, et al. Ambulatory blood pressure monitoring predicts cardiovascular events in treated hypertensive patients—an Anglo-Scandinavian cardiac outcomes trial substudy. J Hypertens. 2009;27:876–85.PubMedCrossRef Dolan E, Stanton AV, Thom S, et al. Ambulatory blood pressure monitoring predicts cardiovascular events in treated hypertensive patients—an Anglo-Scandinavian cardiac outcomes trial substudy. J Hypertens. 2009;27:876–85.PubMedCrossRef
12.
go back to reference Nagy V, Lantos E, Habony N. A study investigating the antihypertensive effect of the fixed combination of perindopril–amlodipine—the PEARL study [in Hungarian]. Lege Artis Med. 2010;20:499–507. Nagy V, Lantos E, Habony N. A study investigating the antihypertensive effect of the fixed combination of perindopril–amlodipine—the PEARL study [in Hungarian]. Lege Artis Med. 2010;20:499–507.
13.
go back to reference Bahl VK, Jadhav UM, Thacker HP. Management of hypertension with the fixed combination of perindopril and amlodipine in daily clinical practice: results from the STRONG prospective, observational, multicenter study. Am J Cardiovasc Drugs. 2009;9:135–42.PubMedCrossRef Bahl VK, Jadhav UM, Thacker HP. Management of hypertension with the fixed combination of perindopril and amlodipine in daily clinical practice: results from the STRONG prospective, observational, multicenter study. Am J Cardiovasc Drugs. 2009;9:135–42.PubMedCrossRef
14.
go back to reference Poulter NR, Wedel H, Dahlof B, et al. Role of blood pressure and other variables in the differential cardiovascular event rates noted in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA). Lancet. 2005;366:907–13.PubMedCrossRef Poulter NR, Wedel H, Dahlof B, et al. Role of blood pressure and other variables in the differential cardiovascular event rates noted in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA). Lancet. 2005;366:907–13.PubMedCrossRef
15.
go back to reference Tedesco MA, Natale F, Calabro R. Effects of monotherapy and combination therapy on blood pressure control and target organ damage: a randomized prospective intervention study in a large population of hypertensive patients. J Clin Hypertens (Greenwich). 2006;8:634–41.CrossRef Tedesco MA, Natale F, Calabro R. Effects of monotherapy and combination therapy on blood pressure control and target organ damage: a randomized prospective intervention study in a large population of hypertensive patients. J Clin Hypertens (Greenwich). 2006;8:634–41.CrossRef
16.
go back to reference Weber MA. Creating a combination antihypertensive regimen: what does the research show? J Clin Hypertens (Greenwich). 2003;5:12–20. Weber MA. Creating a combination antihypertensive regimen: what does the research show? J Clin Hypertens (Greenwich). 2003;5:12–20.
17.
go back to reference O’Brien E, Asmar R, Beilin L, Imai Y, Mancia G, Mengden T, et al. Practice guidelines of the European Society of Hypertension for clinic, ambulatory and self blood pressure measurement. J Hypertens. 2005;23(4):697–701.PubMedCrossRef O’Brien E, Asmar R, Beilin L, Imai Y, Mancia G, Mengden T, et al. Practice guidelines of the European Society of Hypertension for clinic, ambulatory and self blood pressure measurement. J Hypertens. 2005;23(4):697–701.PubMedCrossRef
18.
go back to reference Oparil S. Hypertension in 2010: new challenges in blood pressure goals and assessment. Nat Rev Cardiol. 2011;8:73–5.PubMedCrossRef Oparil S. Hypertension in 2010: new challenges in blood pressure goals and assessment. Nat Rev Cardiol. 2011;8:73–5.PubMedCrossRef
19.
go back to reference O’Brien E. Why ABPM should be mandatory in all trials of blood pressure-lowering drugs. Drug Inf J. 2011;45:233–9. O’Brien E. Why ABPM should be mandatory in all trials of blood pressure-lowering drugs. Drug Inf J. 2011;45:233–9.
Metadata
Title
Twenty-Four-Hour Ambulatory Blood Pressure Reduction with a Perindopril/Amlodipine Fixed-Dose Combination
Author
Viktor L. Nagy
Publication date
01-07-2013
Publisher
Springer International Publishing AG
Published in
Clinical Drug Investigation / Issue 7/2013
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.1007/s40261-013-0086-9

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